GMP Fill Finish Manufacturing
Sterile Product in Vial Filled Aseptically: Solution, Gel-Forming Polymer, or Micronized Suspension
Quality System and GMP Operations
- DDE Labs consists of a Development and GMP Laboratory
- Pharmaceutical development laboratory for developing parenteral formulations, processes, and analytical methods for drug product
- Clean suite for aseptic manufacturing under GMP conditions of early phase clinical trial materials and toxicity test article.
- Injectable solutions, suspensions, and gel formulations
- GMP release and stability testing is conducted for product specific methods
- GMP operation is monitored by on-site QA
- Certificate of Compliance and Certificate of Analysis provided for each batch manufacture
GMP Facility for Manufacture of Clinical Materials
- Flexible facility for phase 1 and early phase 2 clinical material
- GLP toxicity test article
- Hand fill or semi-automated fill in laminar flow hood
- Vials from 1, 5, 10, 20 mL and up
- Batch size up to 10 to 20 liters
- Solution, suspension, viscous liquids, aqueous and non-aqueous
Staging Area for Clean Suite
- Staging area with autoclave, depyrogenation oven, compounding laminar flow hood, pass through and pressure sensors for clean suite, and development lyophilizer
QC Laboratory
- Release of incoming raw materials, QC for manufactured batch, and 24/7 monitored stability chambers with ICH, refrigerated, and frozen storage conditions
- QC Lab for incoming raw material, QC release, and stability testing
- Micro testing and other selected testing outsourced
- Ports for vacuum / gas tubing
Clean Suite from Inside
- Laminar flow hood for compounding
- Separate hood for final fill and finish
- Pass through looking out to QC lab
- Intercom for communication
- Ports for vacuum / gas tubing
